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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Cisplatin, Irinotecan, and Imatinib Mesylate in Patients With Extensive Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	Not specified	NCI	PMH-PHL-008 NCI-5684, NCT00052494, 5684

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more tumor cells.

Phase I trial to study the effectiveness of combining cisplatin, irinotecan, and imatinib mesylate in treating patients who have extensive-stage small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• Measurable disease
• No brain metastases
• No previous chemotherapy
• More than 4 weeks since radiation therapy
• More than 3 weeks since surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 1-hour infusion of cisplatin and a 1-hour infusion of irinotecan once a week for 3 weeks. Treatment may be repeated every 4 weeks for up to four courses. Patients will also receive imatinib mesylate by mouth once a day beginning 1 week before chemotherapy and continuing for 1 week after completing chemotherapy.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Princess Margaret Hospital

Mark Vincent, MD, Protocol chair		Ph: 519-685-8640 Email: mark.vincent@lhsc.on.ca

Registry Information
Official Title		A Phase I Study Of STI 571 (Gleevec) In Combination With Cisplatin/Irinotecan In Patients With Extensive Stage Small Cell Lung Cancer
Trial Start Date		2003-04-24
Trial Completion Date		2009-02-13
Registered in ClinicalTrials.gov		NCT00052494
Date Submitted to PDQ		2002-10-03
Information Last Verified		2005-08-29
NCI Grant/Contract Number		CM17107

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